Sanofi is spending billions of dollars on modern plants that use robotics and analytics to improve manufacturing efficiencies.
Novo has filed a citizen petition saying Victoza’s manufacturing is so complex that equivalence of generics can't be certain without clinical trials.
Three major regulatory bodies – FDA, EMA and Health Canada – changed their guidelines to drug naming. How could these changes impact drug launch timelines?
Dasan E&T was handed an FDA warning letter based on an inspection earlier this year that found numerous testing and manufacturing issues at its plant.
AmerisourceBergen has pled guilty and agreed to pay $260 million to settle a federal case over its sales of cancer meds from an unregistered facility.
The FDA hit Chinese drugmaker Shandong Vianor Biotech with a warning letter and placed the company on an import alert.
The FDA has issued a scathing warning letter to a Pfizer unit that produced EpiPens that failed during emergencies, some of them fatal.
After patient deaths cropped up in multiple myeloma studies featuring Merck’s Keytruda, the FDA isn’t taking any chances with Opdivo.
Hospira issued a voluntary recall of one lot of hydromorphone and four lots of Levophed due to the potential of a lack of sterility.
Last month, following deaths in two Keytruda trials, the FDA halted the pair of Merck studies. And now, it’s warning the public about what’s at stake.
The FDA has taken a close look at Hetero Labs' finished products plant in Telangana, India, and decided it didn't like what it found.